Biosafety regulatory frameworks in Kenya, Nigeria, Uganda and Sweden and their potential impact on international R&D collaborations

Abstract

Gene technologies, such as transgenesis and new breeding techniques (NBTs), expand the toolbox for plant breeding. Many countries in Africa, however, have long been seen as “slow adopters” of gene technologies for several reasons, one being the lack of, or overly restrictive, biosafety regulatory frameworks. This is sometimes attributed to the influence of the precautionary-oriented EU biosafety policies. This study analyses and compares the biosafety regulatory frameworks and their implementation in Kenya, Nigeria and Uganda, and in the EU member state Sweden. The focus is on (1) the structure of the biosafety regulatory frameworks including the scope of the legislation, (2) the duration and cost of regulatory authorization for field trials with genetically modified (GM) plants, and (3) the regulatory approach to NBT products, i.e. to what extent NBT products are subject to the provisions of the biosafety regulatory framework. The data was collected through studying relevant legal and policy documents as well as interviewing regulatory officers and researchers in the respective countries. We found that the regulatory procedures in the selected countries are relatively straightforward, while the costs and duration may present a challenge. The regulatory approach to NBT products differ between the selected African countries and Sweden, the latter which follows EU regulations. The results are discussed in terms of the impact the regulatory developments in these four jurisdictions may have on international R&D collaborations involving the use of gene technologies and we also weigh the results against the common conception that Europe exerts a heavy influence on African countries in this technology field.

The Adoption of Genetically Modified Crops in Africa: the Public’s Current Perception, the Regulatory Obstacles, and Ethical Challenges

“…A sophisticated grasp of socioeconomic dynamics, open communication, and flexible regulatory frameworks are necessary to navigate this evolution. 24 , 45 , 46 The adoption of GM crops in Africa has followed a trajectory that strikes a balance between the benefits and drawbacks, mirroring the larger global conversation about using biotechnology to promote fair and sustainable farming methods. 1 GM crops acceptance or distrust is shaped by current public perception, which is strongly rooted in cultural, economic, and environmental factors.…”

“…Furthermore, regulatory frameworks in Africa vary widely in their approaches, ranging from cautious approval to outright prohibitions. 5 , 24 To support research projects, regional collaboration, and the safe application of GMOs, these frameworks must be harmonized. 15 , 45 Moreover, social justice, environmental consciousness, and cultural values are all entwined with ethical issues.…”

“…Analysis of the regulatory environment surrounding GM crops in several African nations demonstrates a wide range of perspectives and beliefs regarding agricultural biotechnology. 6 , 7 , 24 Although some countries have welcomed GM crops as a way to improve productivity in farming and food security, others have put cautious regulatory frameworks in place that emphasize careful safety evaluations and risk management. On the other hand, some African nations continue to impose strict laws or complete prohibitions due to worries about possible negative effects on the environment, human health, and socioeconomic conditions.…”

“…Emerging patterns in GM crops regulatory strategies suggest that certain nations are investigating flexible regulatory frameworks that strike a balance between promoting agricultural innovation and safety concerns. 6 , 24 , 60 This calls for a more flexible strategy that takes into account risk assessments and continuous scientific developments to guide regulatory choices. 8 , 22 Furthermore, cooperative initiatives are gaining momentum as regional blocs seek to harmonize GM crops regulations.…”

“… 22 , 23 Strong regulatory frameworks prevent accidents during deployment, promote trust among parties, and enable cross-border cooperation. 15 , 24 Responsible practices are guided by ethical considerations that help to mitigate potential negative effects on biodiversity, social equity, and conventional agriculture. 25 , 26 However, the current regulatory frameworks are costly to local African institutions, ineffective with absence of transparency and extremely skeptical of risk.…”